1. Field of the Invention
The present invention relates to devices and methods for treating fractured and/or diseased bone. More specifically, the present invention relates to devices and methods for repairing, reinforcing and/or treating fractured and/or diseased bone using various devices, including cavity-forming devices.
2. Description of the Background
Normal healthy bone is composed of a framework made of proteins, collagen and calcium salts. Healthy bone is typically strong enough to withstand the various stresses experienced by an individual during his or her normal daily activities, and can normally withstand much greater stresses for varying lengths of time before failing. However, osteoporosis or a host of other diseases, including such diseases as breast cancer, hemangiomas, osteolytic metastases or spinal myeloma lesions, as well as the long term excessive use of alcohol, tobacco and/or various drugs, can affect and significantly weaken healthy bone over time. If unchecked, such factors can degrade bone strength to a point where the bone is especially prone to fracture, collapse and/or is unable to withstand even normal daily stresses.
Unfortunately, losses in bone strength are often difficult to discover until bone integrity has already been seriously compromised. For instance, the effects of osteoporosis are often not discovered until after a bone fracture has already occurred, at which time much of the patient""s overall bone strength has typically weakened to dangerous levels. Moreover, as most bone development occurs primarily during childhood and early adulthood, long-term losses in bone strength are typically irreversible. In addition, many bone diseases, including osteoporosis, cancer, and other bone-related disorders, are not routinely curable at our current stage of medical development.
For many individuals in our aging world population, undiagnosed and/or untreatable bone strength losses have already weakened these individuals bones to a point that even normal daily activities pose a significant threat of fracture. For example, when the bones of the spine are sufficiently weakened, the compressive forces in the spine can often cause fracture and/or deformation of the vertebral bodies. For sufficiently weakened bone, even normal daily activities like walking down steps or carrying groceries can cause a collapse of one or more spinal bones, much like a piece of chalk collapses under the compressive weight of a human foot. A fracture of the vertebral body in this manner is typically referred to as a vertebral compression fracture. Researchers estimate that at least 25 percent of all women, and a somewhat smaller percentage of men, over the age of 50 will suffer one or more vertebral compression fractures due to osteoporosis alone. In the United States, it is estimated that over 700,000 vertebral compression fractures occur each year, over 200,000 of which require some form of hospitalization. Other commonly occurring fractures resulting from weakened bones can include hip, wrist, knee and ankle fractures, to name a few.
Fractures such as vertebral compression fractures often result in episodes of pain that are chronic and intense. Aside from the pain caused by the fracture itself, the involvement of the spinal column can result in pinched and/or damaged nerves, causing paralysis, loss of function, and intense pain which radiates throughout the patient""s body. Even where nerves are not affected, however, the intense pain associated with all types of fractures is debilitating, resulting in a great deal of stress, impaired mobility and other long-term consequences. For example, progressive spinal fractures can, over time, cause serious deformation of the spine (xe2x80x9ckyphosisxe2x80x9d), giving an individual a hunched-back appearance, and can also result in significantly reduced lung capacity and increased mortality.
Until recently, treatment options for vertebral compression fractures, as well as other serious fractures and/or losses in bone strength, were extremely limitedxe2x80x94mainly pain management with strong oral or intravenous medications, reduced activity, bracing and/or radiation therapy, all with mediocre results. Because patients with these problems are typically older, and often suffer from various other significant health complications, many of these individuals are unable to tolerate invasive surgery. In addition, to curb further loss of bone strength, many patients are given hormones and/or vitamin/mineral supplementsxe2x80x94again with mediocre results and often with significant side effects.
Over the past decade, a technique called vertebropiasty has been introduced into the United States. Vertebroplasty involves the injection of a flowable reinforcing material, usually polymethylmethacrylate (PMMAxe2x80x94commonly known as bone cement), into a fractured, weakened, or diseased vertebral body. Shortly after injection, the liquid filling material hardens or polymerizes, desirably supporting the vertebral body internally, alleviating pain and preventing further collapse of the injected vertebral body.
While vertebroplasty has been shown to reduce some pain associated with vertebral compression fractures, this procedure has certain inherent drawbacks. The most significant danger associated with vertebroplasty is the inability of the practitioner to control the flow of liquid bone cement during injection into a vertebral body. Although the location and flow patterns of the cement can be monitored by CT scanning or x-ray fluoroscopy, once the liquid cement exits the injection needle, it naturally follows the path of least resistance within the bone, which is often through the cracks and/or gaps in the cancellous and/or cortical bone. Moreover, because the cancellous bone resists the injection of the bone cement and small diameter needles are typically used in vertebroplasty procedures, extremely high pressures are required to force the bone cement through the needle and into the vertebral body. Bone cement, which is viscous, is difficult to inject through small diameter needles, and thus many practitioners choose to xe2x80x9cthin outxe2x80x9d the cement mixture to improve cement injection, which ultimately exacerbates the leakage problems. In a recent study where 37 patients with bone metastases or multiple myeloma were treated with vertebroplasty, 72.5% of the procedures resulted in leakage of the cement outside the vertebral body. Cortet B. et al., Percutaneous Vertebroplasty in Patients With Osteolytic Metastases or Multiple Myeloma (1998). Moreover, where the practitioner attempts to xe2x80x9cthin outxe2x80x9d the cement by adding additional liquid monomer to the cement mix, the amount of unpolymerized or xe2x80x9cfreexe2x80x9d monomer increases, which can ultimately be toxic to the patient.
Another drawback of vertebroplasty is due to the inability to visualize (using CT scanning or x-ray fluoroscopy) the various venous and other soft tissue structures existent within the vertebra. While the position of the needle within the vertebral body is typically visualized, the location of the venous structures within the vertebral body are not. Accordingly, a small diameter vertebroplasty needle can easily be accidentally positioned within a vein in the vertebral body, and liquid cement pumped directly into the venous system, where the cement easily passes out the anterior and/or posterior walls of the vertebrae through the anterior external venous plexus or the basivertebral vein.
Another significant drawback inherent in vertebroplasty is the inability of this procedure to restore the vertebral body to a pre-fractured condition prior to the injection of the reinforcing material. Because the bone is fractured and/or deformed, and not repositioned prior to the injection of cement, vertebroplasty essentially xe2x80x9cfreezesxe2x80x9d the bone in its fractured condition. Moreover, it is highly unlikely that a traditional vertebroplasty procedure could be capable of restoring significant pre-fracture anatomyxe2x80x94because bone cement flows towards the path of least resistance, any enmasse movement of the cortical bone would likely create gaps in the interior and/or walls of the vertebral body through which the bone cement would then immediately flow.
A more recently developed procedure for treating fractures such as vertebral compression fractures and other bone-related disorders is known as Kyphoplasty(trademark). See, for example, U.S. Pat. Nos. 4,969,888 and 5,108,404. In Kyphoplasty, an expandable body is inserted through a small opening in the fractured or weakened bone, and then expanded within the bone. This procedure compresses the cancellous bone, and desirably moves the fractured bone to its pre-fractured orientation, creating a cavity within the bone that can be filled with a settable material such as cement or any number of synthetic bone substitutes. In effect, the procedure xe2x80x9csetsxe2x80x9d the bone at or near its pre-fracture position and creates an internal xe2x80x9ccast,xe2x80x9d protecting the bone from further fracture and/or collapse. This procedure is of course suitable for use in various other bones as well.
While Kyphoplasty can restore bones to a pre-fractured condition, and injected bone filler is less likely to leak out of the vertebral body during a Kyphoplasty procedure, Kyphoplasty requires a greater number of surgical tools than a vertebroplasty procedure, at an increased cost. Moreover, Kyphoplasty tools are typically larger in diameter than vertebroplasty tools, and thus require larger incisions and are generally more invasive.
The present invention overcomes many of the problems and disadvantages associated with current strategies and designs in medical procedures to repair, reinforce and/or treat weakened, diseased and/or fractured bone. In one preferred embodiment, the present invention relates to improved vertebroplasty procedures and surgical instruments which facilitate such procedures.
In a general embodiment of the method of the present invention, an insertion device, preferably an eleven gauge spinal needle assembly, is inserted into a targeted vertebral body using fluoroscopic x-ray to monitor the positioning of the needle. A cavity-forming device is inserted through the needle into the vertebral body. The cavity-forming device desirably compresses cancellous bone in the vicinity of the distal tip of the needlexe2x80x94forming a small cavity within the bone. The cavity-forming device is removed and cement is introduced through the spinal needle. Bone filler such as bone cement mixed with a fluoroscopic agent is injected into the cavity using x-ray fluoroscopy to monitor the flow of the bone filler within the vertebral body. Bone filler introduction is halted when a desired fill amount is reached, the fractured portions of the vertebral body approach and/or return to their pre-fractured position, or bone filler leakage is imminent. Because a cavity is created within the vertebral body prior to bone filler introduction, very low injection pressures can be used, significantly reducing the possibility of cement leakage. In addition, the creation of desired flowpaths permits a greater control in the placement of the bone filler material within the vertebral body.
In another general embodiment of a method of the present invention, an insertion device, such as a commercially available spinal needle assembly, is inserted through a cortical bone region and into a cancellous bone region of a targeted bone using fluoroscopic x-ray to monitor the positioning of the needle. A first material, such as a bone filler, is introduced into the cancellous bone region through the insertion device. An expandable structure is then inserted through the insertion device and expanded in the bone, compressing the first material and/or cancellous bone, thereby creating a cavity and/or a barrier region of compressed cancellous bone substantially surrounding the cavity. A second material, which may be of the same material as the first material, is then introduced through the insertion device into the bone. If desired, the first material can comprise a material having sufficient strength to support the cavity during the surgical procedure, thereby preventing collapse of the cavity upon contraction and removal of the expandable structure. Such first material could include, but is not limited to, bone cement, bone graft material or metallic and nonmetallic stents.
In a further embodiment, the methods of the present invention are performed on a compressed and/or fractured vertebra to strengthen the vertebra, returning it, at least partially, to its pre-fractured position, protect the vertebra from further fracture or collapse, and/or alleviate the pain associated with spinal fractures and compressions.
In one embodiment of the present invention, a cavity-forming device comprises a balloon catheter. The balloon catheter desirably incorporates a hollow tube which extends through a balloon material. At the proximal end of the catheter, the tube and expandable structure are connected to a fitting. At the distal end, the expandable structure is secured directly to and/or around the hollow tube. The distal end of the expandable structure and the distal end of the hollow tube are sealed. Near the distal end of the hollow tube are one or more openings through which an inflation medium passes in and out of the hollow tube to expand and contract the expandable structure.
The balloon catheter of the present invention may be inserted through an insertion device, such as an eleven gauge needle assembly, into a bone, such as a vertebral body, with the distal end of the catheter extending beyond the needle to a length determined by the physician. When the catheter is filled with an inflation medium, the portion of the catheter extending beyond the needle expands outward, compressing cancellous bone and forming a desired cavity within the vertebral body.
In another embodiment of the present invention, the cavity-forming device comprises a shaft incorporating one or more wires or xe2x80x9cbristlesxe2x80x9d at the distal end. The cavity-forming device is desirably inserted through an insertion device, such as a spinal needle, into a cancellous region of a bone, such as a vertebral body. As the bristles enter the vertebral body, they displace cancellous bone in a controlled manner, creating one or more small pathways or cavities in the cancellous bone. The cavity-forming device is removed from the vertebral body and needle, and bone filler is introduced into the vertebral body. The bone filler, which normally flows towards the path of least resistance, will initially flow through the small cavities. If desired, the physician can interrupt introduction of bone filler and create additional cavities by reinserting the cavity-forming device. By creating desired pathways through cancellous bone, the present invention reduces opportunities for cement leakage outside of the vertebral body and/or improves distribution of bone filler through a significant portion of the vertebral body.
Other objects, advantages, and embodiments of the invention are set forth in part in the description which follows, and in part, will be obvious from this description, or may be learned from the practice of the invention.